Some medical procedures require surgical access into the vascular system through an artery or other vessel using, for example, a conventional catheter sheath introducer or dilator for the insertion of certain instruments for both therapeutic and diagnostic procedures. Medical Instruments such as guide wires, catheters, balloon angioplasty devices or the like are typically inserted into the vascular system through a sheath introducer positioned with its distal end extending through a vessel wall. Once the device gains access into the vascular system, it can be advanced to the area requiring a specific medical procedure. The conventional sheath introducer typically has a relatively large outer, diameter, resulting in a correspondingly large wound within the wall of the vessel which must be closed and sealed after the procedure is completed.
It is generally desirable to prevent further bleeding from the blood vessel by sealing the wound as quickly as possible. One common technique to prevent further bleeding is through the application of continuous pressure on the wound until the patient's blood clots sufficiently to seal the vessel. One problem with this common technique, however, is that the application of pressure often requires the dedication of an hour or more of time by the attending medical personnel. Even with such dedicated medical attention, a hematoma can still occur if the patient moves during the clotting process. As a result of these problems, patients can be required to stay at least one night in a hospital for rest and observation. The additional hospital stay is an inconvenience for the patient which also increases the cost associated with the particular medical procedure.
Other instruments for closing surgical wounds and the like are known. These devices typically insert a plug-like object or a clotting agent within the wound area to seal the vessel. The plug or clotting agent can be positioned either within the vessel or outside of the vessel and in close proximity to the outer vessel wall. Various types of plugs have been proposed. For example, collagen plugs are common and are typically designed to be placed outside of the vessel and near the opening within the vessel wall. Somewhat more elaborate plugs have also been proposed for placement directly within the vessel, with the plug secured against the inner vessel wall or lumen by an external suture extending into the wound and attached to the plug. Still other devices accomplish the placement of a clotting agent within the wound area, dispensing a foam, powder or gel within the wound from the distal end of an application device.
A basic shortcoming of the aforementioned instruments is that their use often requires or results in the deposition of plugs or clotting agents within the vessel. This can be unintentional but, even in those instances where the deposition of a plug is to be outside of the vessel, the attending physician may encounter positioning problems so that the plug inadvertently protrudes at least partially into the vessel. Alternatively, the plug may slip into the vessel during the healing process due to the application of external pressure on the wound. In turn, these plugs or clotting agents can partially occlude the flow of blood through the vessel at the site of the original wound, possibly leading to complications such as thrombosis or stenosis. It would be desirable, therefore, to provide an apparatus which avoided the problems and shortcomings of the prior art techniques and devices for closing wounds or incisions within blood vessel in a living patient. Although sutures are very effective generally in closing and sealing surgical wounds, the art has failed to provide an instrument and a method for its use which utilize sutures to close a wound or incision within a vessel. Accordingly, it would be desirable to provide such an apparatus and method which would facilitate the proper placement of sutures within a vascular wound to allow the surgeon or attending medical personnel to quickly and efficiently close and seal such a wound. Most preferably, it is desirable to provide such an apparatus and method which can be used in conjunction with existing medical equipment such as conventional catheter sheath introducers, for example.
Accordingly, it is a general object of the present invention to provide a wound closure apparatus and a method for closing vascular wounds, including surgical wounds.
It is a further object of the invention to provide a wound closure apparatus and a method for its use which facilitate the proper placement of sutures for the closure of vascular wounds.
It is still another object of the invention to provide a wound closure apparatus and a method for its use which can be used with conventional medical equipment such as a catheter sheath introducer, for example.